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Recall Observatory FDA recall evidence

Device product

CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..

Z-3082-2017

August 10, 2017

Class II

Product summary

Firm
Med Tec Inc
Event
Event 77874
Status
Terminated
Classification
Class II
Quantity
101 units
Official record key
device-enforcement:Z-3082-2017

Official wording

Reason: Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.

Code information: Codes: M207190, M212200, M141830, M142280, M144220, M149540, M149550, M149560, M149580, M164440, M164470, M177290, M177330, M177340, M198070, M198100, M285840, M133130, M137690, M138630, M138640, M138650, M165550, M165560, M180420, M180430, M180440, M189150, M217660, M217670, M217680, M217710

Distribution pattern: Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.